At last! It has been a long time in the running, but IEC have recently released IEC 62366-1 and 62366-2, which supercede the IEC/ISO 62366 standard. These documents in this standard continue to cover the application of usability engineering to medical devices. It builds upon the existing standard to bring more harmony between the requirements…
DetailsWhen developing a pen injector (or injection pen as also commonly known), it is prudent to understand the performance of the device from a clinical perspective. ISO have a standard that details suitable methods for determining the dose accuracy of a pen injector, and this standard is called ISO 11608: “Needle based injection systems for…
DetailsJust recently a colleague had mentioned to me that he had lost two of his best (and most expensive) shirts as they had been severely shrunk in the washing machine. He joked that the current size would probably have fitted him 20 years ago. This was the outcome of a simple mistake, he had set…
DetailsTHAY Medical were proud to have taken part in the Med-Tech Innovation Exhibition, which took place on 28th and 29th April 2015 at the Ricoh Arena, Coventry, UK. For those who don’t know, the Med-Tech Innovation Exhibition is one of the largest medical device events to take place in the UK. The exhibitors were from…
DetailsWhen it comes to evaluating patients who have a degenerative condition, it is never straight-forward to predict what the outcomes of any research or evaluation will be. With Parkinson’s disease, there are the ethical, moral and safety considerations that may greatly affect the data generated from an evaluation – especially in a human factors/usability study. People…
DetailsIt is good that some projects require a level of understanding of the human body, how it works and how medical devices interact with the human body in a very specific area. We are currently learning about blood and the area of plasmapheresis. Now this is a specialist area! Linked to…
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